Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients

Ankle Brachial Index Clinical Trial

Official title:

Adding Ankle Brachial Index to Traditional Framingham Risks Can Improve All-cause Mortality and Cardiac Mortality Prediction in Medium and High Framingham Risk Score Patients: A China Prediction Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811547
• Other study ID #: AIRPORTS
• Status: Completed
• Start date: November 20, 2011
• Est. completion date: May 10, 2017

Study information

• Verified date: March 2021
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Framingham Risk Score (FRS) included age, gender, body mass index (BMI), cigarette smoking, blood pressure, total cholesterol (TC), LDL-cholesterol (LDL-C) and diabetes mellitus (DM). Previously, Framingham cohort study and other study has confered patients with medium or high FRS had worse prognosis. However, the score list was tending to over-estimate risk in medium FRS or under-estimate risk in high FRS patients . For this reason, ACC/AHA cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ASCVD) risk assessment and medical decision making.

Meanwhile, the ABI, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (PAD) in the legs. Several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . In addition, ABI aggressively modified risk factors and accelerated the adverse prognosis of ASCVD. However, whether FRS or ABI, were all related to participants and race. And, most studies were from western countries, lack of Asian date, especially aimed at risk prediction model research. Therefore, this research was aimed to validate incorporating ABI and relevant Framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high Framingham risk score (FRS) patients.

Description:

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3687
• Est. completion date: May 10, 2017
• Est. primary completion date: March 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The inclusion criteria:

1. Patients were age older than or equal to 18 years

2. Patients with medium and high Framingham risk score,namely, Framingham Risk Score (FRS) 10%-20%,or FRS > 20%.

3. All participants gave written informed consent to this study, which was approved by the ethics committee of Tongji University.

Exclusion Criteria:

1. Patients were suffering from mental illness.

2. Life expectancy of patients were less than 1 year.

Related Conditions & MeSH terms

• Ankle Brachial Index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Causes mortality and Cardiac mortality	In this study, the Cardiac death was only cardiac event death. Medical records and death certificates of all patients who had an event were obtained and validated by cardiologist. Death was confirmed from hospital records or by contact with participants and their families. All materials were reviewed independently by five senior physicians of the cohort study to confirm the cause of death.	from November 2011 to June 2018
Secondary	New-onset Cardiovascular Events	New-onset Cardiovascular events are composed of cardiac including non-fatal myocardial infarction, unstable angina, and coronary revascularization procedures during follow-up time. Exclusion criteria were stale angina (>6 months), revascularization procedure for CAD ( >6 months) and myocardial infarction( >6 months).	from November 2011 to June 2018